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NCT07361497PHASE3Recruiting

A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)

Bristol-Myers Squibb

Start Date

3/16/2026

Completion Date

1/13/2034

Summary

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease. * Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy). * Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT). * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. Exclusion Criteria * Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements. * Participants must not have an active autoimmune disease. * Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage. * Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis. * Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

Pumitamig

DRUG

Durvalumab

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Conditions

Non-small Cell Lung Cancer (NSCLC)

Locations

Southern Cancer Center Pc

Daphne, Alabama 36526

United States

Intermountain Health Cancer Center Lutheran Hospital

Golden, Colorado 80401

United States

Medical Oncology Hematology Consultants, PA

Newark, Delaware 19713

United States

Local Institution - 0711

Ocala, Florida 34474

United States

Local Institution - 0935

Plantation, Florida 33322

United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia 30060

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Endeavor Health

Evanston, Illinois 60201

United States

Illinois Cancer Care

Peoria, Illinois 61615

United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana 46804

United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky 40536

United States

Local Institution - 0603

Boston, Massachusetts 02114-2621

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Minnesota Oncology Hematology

Maple Grove, Minnesota 55369

United States

Allina Health Cancer Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota 55407

United States

Missouri Cancer Associates

Columbia, Missouri 65201

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Local Institution - 0339

Westbury, New York 11590

United States

Optum Medical Care, PC

Westbury, New York 11590

United States

Novant Health Pharmacy Oncology Specialists

Winston-Salem, North Carolina 27103

United States

Akron General Medical Center

Akron, Ohio 44302

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Cleveland Clinic - Hillcrest Hospital

Mayfield Heights, Ohio 44124

United States

Oncology Associates Of Oregon, Pc

Eugene, Oregon 97401

United States

Northwest Cancer Specialists, P.C.

Happy Valley, Oregon 97015

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

Texas Oncology - Amarillo Cancer Center

Amarillo, Texas 79124

United States

Texas Oncology-Austin Central

Austin, Texas 78731

United States

Texas Oncology

Denton, Texas 76210

United States

The Center For Cancer And Blood Disorders

Fort Worth, Texas 76104

United States

The University of Texas-MD Anderson Cancer Center

Houston, Texas 77030

United States

Texas Oncology - San Antonio Medical Center

San Antonio, Texas 78229

United States

Texas Oncology - Northeast Texas

Tyler, Texas 75702

United States

Blue Ridge Cancer Care

Christiansburg, Virginia 24073

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Instituto Argentino De Diagnostico Y Tratamiento IADT

Buenas Aires, Buenos Aires C1049AAG

Argentina

Investigaciones Oncologicas C Colon SA

Mar del Plata, Buenos Aires 7600

Argentina

Hospital Privado Universitario de Córdoba

Córdoba, Córdoba Province 5016

Argentina

Sanatorio Parque Rosario

Rosario, Santa Fe Province 2000

Argentina

Instituto Medico Especializado Alexander Fleming

Buenos Aires, 1426

Argentina

Clinica Adventista Belgrano

Buenos Aires, 1430

Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABB

Argentina

Instituto de Investigaciones Clínicas Córdoba S.A.

Córdoba, X5000

Argentina

Gosford Hospital

Gosford, New South Wales 2250

Australia

Nepean Hospital

Penrith, New South Wales 2750

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia 5112

Australia

Grampians Health

Ballarat Central, Victoria 3350

Australia

Northern Hospital

Epping, Victoria 3076

Australia

Joondalup Health Campus

Joondalup, Western Australia 6027

Australia

Universitätsklinik Innsbruck

Innsbruck, 6020

Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, 4020

Austria

Medizinische Universitaet Wien/AKH

Vienna, 1090

Austria

Local Institution - 0122

Anderlecht, Bruxelles-Capitale, Région de 1070

Belgium

Grand Hôpital de Charleroi

Charleroi, Hainaut 6060

Belgium

Ziekenhuis Oost-Limburg, Campus St.-Jan

Genk, Limburg 3600

Belgium

UZ Gent

Ghent, Oost-Vlaanderen 9000

Belgium

VITAZ

Sint-Niklaas, Oost-Vlaanderen B-9100

Belgium

UZ Leuven

Leuven, Vlaams-Brabant 3000

Belgium

Algemeen Ziekenhuis klina

Brasschaat, 2930

Belgium

Vencer Centro de Pesquisa LTDA

Teresina, Piauí 64049-200

Brazil

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte 59062-000

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo 14784400

Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo 15090-000

Brazil

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, 01246-000

Brazil

Multiprofile Hospital for Active Treatment - Haskovo AD

Haskovo, 6304

Bulgaria

Complex Oncology Center - Ruse EOOD

Rousse, 7002

Bulgaria

"Sveta Ekaterina" Hospital

Sofia, 1431

Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, 1527

Bulgaria

Diagnostic and Consultative Center Convex

Sofia, 1680

Bulgaria

The Ottawa Hospital - General Campus

Ottawa, Ontario K1H 8L6

Canada

St. Marys Hospital Center

Montreal, Quebec H3T 1M5

Canada

IUCPQ

Québec, G1V 4G5

Canada

Bradford Hill Norte

Antofagasta, AN 1240000

Chile

Centro de Oncología de Precisión

Las Condes, Arica y Parinacota Region 7560908

Chile

FALP

Santiago, Santiago Metropolitan 7500921

Chile

Bradfordhill

Santiago, Santiago Metropolitan 8420383

Chile

Oncocentro APYS - Centro de Atencion Medica Oncologica Integral

Viña del Mar, Valparaiso 2520612

Chile

Beijing Cancer hospital

Beijing, Beijing Municipality 100142

China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality 400030

China

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong 515041

China

Peking University Shenzhen Hospital

Shenzhen, Guangdong 518036

China

Local Institution - 0249

Zhengzhou, Henan 450008

China

Jingzhou First People's Hospital

Jingzhou, Hubei 0

China

The Central Hospital of Wuhan

Wuhan, Hubei 430014

China

Local Institution - 0813

Wuhan, Hubei 430030

China

Local Institution - 0489

Changsha, Hunan 410031

China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu 215006

China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

Local Institution - 0242

Shenyang, Liaoning 110042

China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi 710004

China

Local Institution - 0564

Xi'an, Shaanxi 710061

China

Qilu Hospital of Shandong University

Jinan, Shandong 250012

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

Local Institution - 0248

Shanghai, Shanghai Municipality 200433

China

Shanxi Cancer Hospital

Taiyuan, Shanxi 030000

China

Sichuan Cancer hospital

Chengdu, Sichuan 610041

China

Local Institution - 0440

Chengdu, Sichuan 610066

China

The second Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang 310000

China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang 310022

China

Taizhou Hospital Of Zhejiang Province

Linhai, Zhejiang 317000

China

Sun Yat-sen University Cancer Center

Guangzhou, 510060

China

Local Institution - 0537

Shanghai Shi, 200030

China

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine 33076

France

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes 69373

France

Local Institution - 0129

Dijon, Côte-d'Or 21079

France

Institut Régional du Cancer Montpellier

Montpellier, Hérault 34298

France

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

Saint-Herblain, Loire-Atlantique 44800

France

CHU de Toulouse - Hopital Larrey

Toulouse, Midi-Pyrénées 31400

France

CHU Lille - Institut Coeur Poumon

Lille, Nord 59037

France

Local Institution - 0689

Villejuif, Val-de-Marne 94800

France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, 87042

France

Assistance Publique Hôpitaux de Marseille - Hôpital Nord

Marseille, 13915

France

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, 75014

France

Klinikum Augsburg

Augsburg, Bavaria 86156

Germany

Local Institution - 0929

Erlangen, Bavaria 91054

Germany

Katholisches Klinikum-Koblenz Marienhof

Koblenz, Rhineland-Palatinate 56073

Germany

Klinikum der Stadt Ludwigshafen gGmbH

Ludwigshafen am Rhein, Rhineland-Palatinate 67063

Germany

Local Institution - 0934

Magdeburg, Saxony-Anhalt 39120

Germany

Universitatsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein 24105

Germany

Universitaetsklinikum Jena

Jena, Thuringia 7747

Germany

Local Institution - 0217

Berlin, 10117

Germany

Local Institution - 0931

Berlin, 12351

Germany

Local Institution - 0215

Berlin, 14165

Germany

Local Institution - 0169

Göttingen, 37075

Germany

Asklepios Fachkliniken Muenchen-Gauting

Gröbenzell, 82194

Germany

Krankenhaus Martha-Maria Halle-Doelau Ggmbh

Haile, 06120

Germany

LungenClinic Grosshansdorf GmbH

Hamburg, 22045

Germany

Lungenfachklinik Immenhausen

Immenhausen, 34376

Germany

Universitaetsklinikum Regensburg

Regensburg, 93053

Germany

Thoracic General Hospital of Athens "I Sotiria"

Athens, Attikí 115 27

Greece

General Hospital of Athens "Laiko"

Athens, Attikí 11527

Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Thessaloníki 564 29

Greece

G. Papanikolaou General Hospital

Thessaloniki, Thessaloníki 570 10

Greece

University General Hospital of Larissa

Larissa, Thessalía 41110

Greece

Errikos Dunant Hospital Center

Athens, 115 26

Greece

Local Institution - 0457

Tuenmen, NT 0

Hong Kong

Queen Mary Hospital

Hksar, 999077

Hong Kong

Local Institution - 0764

Shatin, 0

Hong Kong

Local Institution - 0139

Kecskemét, Bács-Kiskun county 6000

Hungary

Local Institution - 0787

Szolnok, Jász-Nagykun-Szolnok 5000

Hungary

Local Institution - 0138

Budapest, 1121

Hungary

Local Institution - 0776

Farkasgyepű, 8582

Hungary

Local Institution - 0696

Törökbálint, 2045

Hungary

Local Institution - 0840

Eluru, Andhra Pradesh 534002

India

Local Institution - 0927

Goraj, Gujarat 391760

India

Local Institution - 0548

Pūlakkōd, Kerala 673601

India

Local Institution - 0864

Aurangabad, Maharashtra 431002

India

Local Institution - 0660

Mumbai, Maharashtra 400012

India

Local Institution - 0663

Mumbai, Maharashtra 400036

India

Local Institution - 0661

Nagpur, Maharashtra 440001

India

Local Institution - 0664

Dwarka, National Capital Territory of Delhi 110075

India

Local Institution - 0856

New Delhi, National Capital Territory of Delhi 110085

India

Local Institution - 0657

Hyderabad, Telangana 500033

India

Local Institution - 0547

Delhi, 110029

India

Local Institution - 0659

Pune, 411001

India

Local Institution - 0276

Cork, T12K199

Ireland

St. James's Hospital

Dublin, D08 E9P6

Ireland

Beaumont Hospital, Dublin

Dublin, D9

Ireland

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Campania 80131

Italy

Ospedale Santa Maria delle Croci

Ravenna, Emilia-Romagna 48121

Italy

Cro-Irccs

Aviano, Friuli Venezia Giulia 33081

Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Piedmont 10043

Italy

Policlinico Universitario Campus Bio-Medico

Rome, Roma 00128

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Istituto Europeo di Oncologia IRCCS

Milan, 20141

Italy

Azienda Ospedaliero Universitaria di Parma

Parma, 43126

Italy

Local Institution - 0014

Nagoya, Aichi-ken 464-8681

Japan

Kobe University Hospital

Kobe, Hyōgo 650-0017

Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo 663-8501

Japan

Kitasato University Hospital

Sagamihara, Kanagawa 252-0375

Japan

Kanagawa cancer center

Yokohama, Kanagawa 2418515

Japan

Sendai Kousei Hospital

Sendai, Miyagi 9810914

Japan

Kansai Medical University Hospital

Hirakata, Osaka 573-1191

Japan

Kindai University Hospital

Sakai, Osaka 590-0197

Japan

Saitama Medical University International Medical Center

Hidaka, Saitama 350-1298

Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka 431-3192

Japan

Tokyo Metropolitan Komagome Hospital

Bunkyo Ku, Tokyo 113-8677

Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395

Japan

Okayama University Hospital

Okayama, 700-8558

Japan

Local Institution - 0759

Sendai, 980-8574

Japan

Local Institution - 0772

Saltillo, Coahuila 25279

Mexico

Local Institution - 0815

Tijuana, Estado de Baja California 22010

Mexico

Local Institution - 0699

Zapopan, Jalisco 45050

Mexico

Local Institution - 0330

Monterrey, Nuevo León 64460

Mexico

Local Institution - 0914

Puebla City, 72530

Mexico

Local Institution - 0349

Querétaro, 76000

Mexico

Radboudumc

Nijmegen, Gelderland 6525 GA

Netherlands

Amphia Ziekenhuis, locatie Breda Molengracht

Breda, North Brabant 4818 CK

Netherlands

Local Institution - 0091

Amsterdam, North Holland 1081 HV

Netherlands

Local Institution - 0087

Zwolle, Overijssel 8025 AB

Netherlands

University Medical Center Groningen

Groningen, 9713 GZ

Netherlands

Local Institution - 0092

Tilburg, 5000 LA

Netherlands

Local Institution - 0473

Lublin, Lublin Voivodeship 20-954

Poland

SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

Opole, Opole Voivodeship 45-061

Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

Przemyśl, Podkarpackie Voivodeship 37-700

Poland

Uniwersyteckie Centrum Kliniczne im. prof. K.Gibinskiego SUM w Katowicach

Katowice, Silesian Voivodeship 40-853

Poland

Centrul de Diagnostic si Tratament Provita

Bucharest, Bucharest 020335

Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj 407280

Romania

Spitalul Universitar de Urgență București

Bucharest, 050098

Romania

Institutul Oncologic Cluj

Cluj-Napoca, 400015

Romania

Centrul de Oncologie Sf. Nectarie SRL

Craiova, 200542

Romania

S.C. Centrul de Oncologie Euroclinic S.R.L.

Iași, 700106

Romania

Institutul Regional de Oncologie

Iași, 700483

Romania

Oncomed

Timisoara, Timis, 300239

Romania

National Cancer Centre Singapore

Singapore, 168583

Singapore

Local Institution - 0647

Singapore, 308442

Singapore

Chungbuk National University Hospital

Cheongju-si, Chungcheongbuk-do [Chungbuk] 28644

South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do 13620

South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul] 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul] 03722

South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 05505

South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 06351

South Korea

Local Institution - 0041

L'Hospitalet Del Llobregat, Barcelona [Barcelona] 08908

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña] 08041

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de 28041

Spain

Hospital Clinico de Valencia

Valencia, Valenciana, Comunitat 46010

Spain

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

Barakaldo, 48903

Spain

Parc de Salut Mar - Hospital del Mar

Barcelona, 08003

Spain

Hospital Universitario Virgen De La Victoria

Málaga, 29010

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009

Spain

Sjukhuset I Gävle

Gävle, Gävleborgs Län [se-21] 80187

Sweden

Karolinska Universitetssjukhuset Solna

Solna, Stockholms Län [se-01] 171 64

Sweden

Akademiska sjukhuset

Uppsala, Uppsala Län [se-03] 751 85

Sweden

Universitaetsspital Basel

Basel, 4031

Switzerland

Ospedale Regionale Bellinzona e Valli

Bellinzona, CH-6500

Switzerland

Kantonsspital Münsterlingen - Spital Thurgau AG

Münsterlingen, 8596

Switzerland

Kantonsspital St Gallen

Sankt Gallen, 9007

Switzerland

National Taiwan University Hospital - Hsinchu branch

Zhubei, Hsinchu 302

Taiwan

Far Eastern Memorial Hospital

New Taipei City, 220

Taiwan

Taichung Veterans General Hospital

Taichung, 407

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Local Institution - 0733

Bangkok, 10700

Thailand

Local Institution - 0917

Chiang Mai, 50200

Thailand

Local Institution - 0160

Khon Kaen, 40002

Thailand

Local Institution - 0728

Songkhla, 90110

Thailand

Local Institution - 0099

Adana, 01140

Turkey (Türkiye)

Local Institution - 0113

Adana, 01370

Turkey (Türkiye)

Local Institution - 0198

Antalya, 07100

Turkey (Türkiye)

Local Institution - 0109

Çankaya, 06680

Turkey (Türkiye)

Local Institution - 0096

Istanbul, 34214

Turkey (Türkiye)

Local Institution - 0107

Istanbul, 34732

Turkey (Türkiye)

The Christie NHS Foundation Trust

Manchester, Lancashire M20 4BX

United Kingdom

Local Institution - 0932

Newcastle upon Tyne, North East NE77DN

United Kingdom

Local Institution - 0928

Birmingham, West Midlands B9 5SS

United Kingdom

Addenbrooke's Hospital

Cambridge, CB2 2QQ

United Kingdom

Velindre Cancer Centre

Cardiff, CF14 2TL

United Kingdom

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU2 7XX

United Kingdom

Local Institution - 0693

Leeds, LS9 7TF

United Kingdom

Clatterbridge Cancer Centre - Liverpool

Liverpool, L9 7BA

United Kingdom

University College London Hospital

London, NW1 2BU

United Kingdom

Royal Marsden Hospital (Chelsea)

London, SW3 6JJ

United Kingdom

Mount Vernon Hospital

Middlesex, DA146LT

United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT

United Kingdom